Fibromyalgia is a common disabling disorder characterized by chronic musculoskeletal aches and pain, stiffness, general fatigue, and sleep abnormalities including diminished stage four sleep. Examination of affected patients reveals increased tenderness at muscle and tendon insertion sites, known as "tender points". Fibromyalgia patients experience severe morning stiffness and a generalized decreased of overall physical function, and they are often prone to headaches, memory and concentration problems, dizziness, numbness and tingling, and crampy abdominal or pelvic pain. Fibromyalgia affects 2-4% of the population and is most frequently found in women between 20 and 50 years old, though it can also affect men, the elderly and minors.
Diagnosis of fibromyalgia is often overlooked due to the general nature of the symptoms and the lack of diagnostic lab or x-ray abnormalities. The disorder is often concomitant with, masked by or confused with other diseases such as rheumatoid arthritis, chronic fatigue syndrome or irritable bowl syndrome. A physician can positively diagnosis fibromyalgia syndrome by finding the symptoms of generalized musculoskeletal pain and pain at more than 11 of 18 defined characteristic "tender points" when finger pressure of about 4 kg is applied to the area, which test is known as the "tender point index".
Currently the best treatment available for fibromyalgia consists of a combination of analgesics, sleep aids, exercise programs emphasizing stretching and cardiovascular fitness, relaxation techniques and other measures to reduce muscle tension, and educational programs to reduce emotional and physical stress. Numerous pharmaceutical regimes have been tried including treatment with serotonin modulators and antisera to endogenous psychoactive agents. Therapeutic response can be assessed by the reduction of pain in the tender point index and improvement in several generalized criteria such as physical function, stiffness, fatigue, depression, tenseness, etc. Responses to these various therapies have proven variable within a patient pool and have rarely exceeded modest relief of some symptoms. Often, initial therapeutic gains are temporary with the long term outcome marginally if at all distinguishable from placebo results.
There exists a significant need for more effective therapy for patients afflicted with fibromyalgia. The present invention is directed to a method for treating the disease condition (as measured by reduction of clinical symptoms) by treating a fibromyalgia afflicted patient with low doses of interferon administered either bucally, sublingually or by oral ingestion. In one embodiment a Type I interferon is administered in a solid or liquid dosage form by oral ingestion, or it is administered to the oral and pharyngeal mucosa of a patient diagnosed with fibromyalgia at a dose of about 1 to about 1500 IU interferon per day, more preferably, about 5 to about 1000 IU per day. In another embodiment interferon is administered orally in doses of about 10 to about 250 IU per day. In another embodiment, interferon administered is about 15 to about 150 IU per day. The daily doses can be divided into multiple dosages forms administered two or more times per day.
Interferon for oral ingestion administration in accordance with the present invention can be formulated using art-recognized techniques into pharmaceutically acceptable liquid carriers or in combination with pharmaceutically acceptable solid carriers in the form of tablets, capsules, caplets, or gel-seals.
Interferon for buccal or sublingual administration to the patient's oral and pharyngeal mucosa can be formulated in liquid forms or in solid forms using a saliva soluble carrier to form saliva soluble solid dosage forms which can be held in the mouth for a time sufficient to dissolve the dosage form and form an interferon-containing saliva solution in contact with the patient's oral and pharyngeal mucosa to stimulate a therapeutic effect.